A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study Comparing the Safety and Efficacy of IDP-120 Gel and IDP-120 Vehicle Gel in the Treatment of Acne Vulgaris
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 585
- 试验地点
- 20
- 主要终点
- Absolute Change in Mean Lesion Counts at Week 12
研究概览
简要总结
study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel and IDP-120 Vehicle Gel
详细描述
This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel and IDP-120 Vehicle Gel at Weeks 2, 4, 8, and 12. To be eligible for the study subjects must be at least 9 years of age and have a clinical diagnosis of moderate to severe acne
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) As a double-blinded study, the investigators, the site staff, the sponsor, and the clinical monitors will not be aware of the treatment assigned to the individual study subjects
入排标准
- 年龄范围
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female at least 9 years of age and older;
- •Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit);
- •Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity Score (EGSS) assessment at the baseline visit;
- •Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20 but no more than 50;
- •Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than 25 but no more than 100;
- •Subjects with two or fewer facial nodules
排除标准
- •Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study;
- •Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis, eczema;
- •Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive;
- •Subjects with a facial beard or mustache that could interfere with the study assessments;
- •Subjects with more than two (2) facial nodules;
- •Evidence or history of cosmetic-related acne
研究组 & 干预措施
IDP-120 Gel
IDP-120 Gel, once-daily application
干预措施: IDP-120 Gel (Drug)
IDP-120 vehicle gel
IDP-120 vehicle gel, once daily application
干预措施: IDP-120 Vehicle Gel (Drug)
结局指标
主要结局
Absolute Change in Mean Lesion Counts at Week 12
时间窗: Baseline to Week 12
For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.
Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) and Had an EGSS at Week 12 That Equated to "Clear" or "Almost Clear"
时间窗: Baseline to Week 12
Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe.
次要结局
- Percentage Change in Mean Lesion Counts at Week 12(Baseline to Week 12)
- Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS)(Baseline to Week 12)
- Percentage Change in Mean Lesion Counts at Week 8(Baseline to Week 8)
- Percentage Change in Mean Lesion Counts at Week 4(Baseline to Week 4)